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Clinical Trial for Cardiac Ablation for Type I Atrial Flutter.

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Presentation on theme: "Clinical Trial for Cardiac Ablation for Type I Atrial Flutter."— Presentation transcript:

1 Clinical Trial for Cardiac Ablation for Type I Atrial Flutter

2 DISCLAIMER Boston Scientific Education and Presentation Resources Boston Scientific develops, manufactures and markets a broad array of products and services that enable less- invasive care for some of the most threatening cardiac conditions. Its prescription devices for use by healthcare professionals are regulated by government agencies in each of the countries in which it does business, such as the Food and Drug Administration in the United States (U.S.) or the Ministry of Health in Japan. These regulations often restrict the use of the information that can be disclosed to the public. If the format of the material presented is altered, the appropriate indications, contraindications, precautions, warnings and adverse events should be included. This Presentation has been developed as a service of Boston Scientific. Like any other service, in spite of our best efforts the information in this Presentation may become out of date over time. Nothing on this Presentation should be construed as the giving of advice or the making of a recommendation and it should not be relied on as the basis for any decision or action. The materials on this Web Site are intended for educational purposes only. Boston Scientific accepts no liability for the accuracy or completeness or use of, nor any liability to update, the information contained on this Presentation. These materials are provided "AS IS" WITHOUT WARRANTY OF ANY KIND, EITHER EXPRESSED OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT. Some jurisdictions do not allow the exclusion of implied warranties, so the above exclusion may not apply to you. Copyright and Intellectual Property Boston Scientific hereby authorizes you to copy materials published by it on the Cardiac Rhythm Resources Web Site for non commercial use only, provided any copy of these materials which you make shall retain all copyright and other proprietary notices and any disclaimer contained thereon and on this Web Site. Nothing contained herein shall be construed as conferring by implication or otherwise any license or right under any patent or trademark of Boston Scientific or any third party. Except as expressly provided above, nothing contained herein shall be construed as conferring any license or right under any Boston Scientific copyright. Illustrations with the mark ©medmovie.com, are Copyright medmovie.com with all rights reserved.

3 Blazer II XP Temperature Ablation Catheter Clinical Trial for Cardiac Ablation for Type I Atrial Flutter Status: Approved in 2003 First clinical trial to prove the safety and effectiveness of 8- and 10-mm-tip ablation catheters used with a 100 W cardiac ablation system for the treatment of type 1 atrial flutter

4 Design * Prospective, multicenter, single-arm study using objective performance criteria and historical control data from the medical literature Eligible patients had sustained or recurrent type 1 atrial flutter Procedural success was defined as complete bidirectional isthmus block with noninducible type 1 atrial flutter with only the use of the Blazer II XP Catheter and EPT-1000XP Cardiac Ablation System and accessories Chronic success was demonstration of acute procedural success and continued absence of targeted type 1 atrial flutter for 6 months after the ablation procedure Procedural safety was the absence of serious complications associated with the use of the Blazer II XP Catheter and EPT-1000XP System within 7 days of the ablation procedure Clinical follow-up was performed at 1, 3, and 6 months, and at 1 and 2 years following the procedure * Summary of Safety and Effectiveness Data. Blazer II XP Cardiac Ablation Catheter, Boston Scientific Corporation, Data can be found at: Enter product name into search field.

5 Patient Population * Eligible study participants included both male and female patients over 18 years of age that had experienced 2 documented episodes of atrial flutter (by ECG, Holter, rhythm strip or ICD) within 6 months prior to enrollment or who had 1 documented episodes of atrial flutter (ECG, Holter, rhythm strip, or ICD) during the 6 months preceding study enrollment. Some of the exclusion criteria were: –Patients with a direct remedial cause of atrial flutter (e.g., thyroid disease, pericarditis, pulmonary embolic disease) –Patients with any prior isthmus cardiac ablation for type 1 AFL –Patients in treatment for non-atrial flutter (type 1) arrhythmias with anti- arrhythmic drugs (class IA, IC, or III) within three months preceding study entry –Patients who received cardiac ablation or cardioversion for other types of non- atrial flutter (type 1) arrhythmias within 3 months preceding study entry. 23 US centers 250 patients enrolled * Summary of Safety and Effectiveness Data. Blazer II XP Cardiac Ablation Catheter, Boston Scientific Corporation, Data can be found at: Enter product name into search field.

6 Clinical Relevance * To evaluate the safety and effectiveness of large- tip catheter ablation in patients with type 1 atrial flutter The primary endpoints were acute procedural success, chronic (6 month) success, and complication rate per Bayesian analysis First trial to demonstrate the safety and effectiveness of 8- and 10-mm tip catheters used with a 100 W system for the treatment of type 1 atrial flutter * Summary of Safety and Effectiveness Data. Blazer II XP Cardiac Ablation Catheter, Boston Scientific Corporation, Data can be found at: Enter product name into search field.

7 Results 1 Summary of Safety and Effectiveness Data. Blazer II XP Cardiac Ablation Catheter, Boston Scientific Corporation, Data can be found at: Enter product name into search field 2 Of the 235 acute success patients, 84 patients were not included in the follow-up: 30 patients had not completed their 6-month follow-up at the time the Summary of Safety and Effectiveness Data was reported to the FDA, and 54 were not considered due to: persistent atrial fibrillation (1), death (5), withdrawal or lost to follow-up (6), implanted pacemakers or defibrillators (11), and treatment with Class IA, IC, or III antiarrhythmic drugs (31). 3 Patients who reached 6-month follow-up and were not on class IA, IC, or III antiarrhythmic drugs. 4 Total procedure time defined as the time of first diagnostic catheter insertion until the last diagnostic catheter withdrawal (Source: BSCI/EP Technologies US Atrial Flutter Study Procedure Logistics Form, Rev G – 7/12/2001 – PROCLOG2).

8 Additional References Feld G, Wharton M, Plumb V, Daoud E, Friehling T, Epstein L, for the EPT-1000 XP Cardiac Ablation System Investigators. Radiofrequency catheter ablation of type 1 atrial flutter using large-tip 8- or 10- mm electrode catheters and a high-output radiofrequency energy generator: Results of a multicenter safety and efficacy study. J Am Coll Cardiol 2004; 43:


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